Pharmacovigilance Compliance Manager

Why This Role Matters

Corrective and Preventive Action (CAPA) management is a vital component of quality and compliance systems in pharmacovigilance and regulatory operations. CAPA processes ensure that safety, compliance, and operational issues are systematically investigated, resolved, and prevented from recurring.
The CAPA Manager role at Tata Consultancy Services plays an important role in maintaining pharmacovigilance quality standards. The position focuses on identifying root causes of issues, implementing corrective actions, and ensuring regulatory compliance across drug safety operations.
This role contributes to improving pharmacovigilance processes, supporting regulatory inspections, and strengthening compliance with global safety regulations. Professionals working in CAPA management help organizations maintain strong quality systems and ensure that safety operations meet global regulatory expectations. For candidates with experience in pharmacovigilance quality systems, audits, and SOP documentation, this role offers the opportunity to work in a structured regulatory environment while collaborating with multiple stakeholders.

Job Description

Tata Consultancy Services is hiring a CAPA Manager to support pharmacovigilance quality and compliance activities within its Business Process Services division. The selected candidate will be responsible for identifying issues, conducting root cause analyses, and developing corrective and preventive action plans to ensure regulatory compliance and operational improvement. The role involves collaboration with cross-functional teams, client interaction, and oversight of CAPA implementation and effectiveness. The CAPA Manager will also support audits, inspections, and continuous improvement initiatives by maintaining accurate documentation and ensuring compliance with regulatory standards.

Key Features of the Role

• Opportunity to work in pharmacovigilance quality and compliance management
• Exposure to global regulatory frameworks and drug safety standards
• Involvement in CAPA development, implementation, and monitoring
• Participation in audit and inspection readiness activities
• Collaboration with cross-functional teams and external stakeholders
• Opportunity to contribute to continuous improvement in pharmacovigilance processes

Responsibilities

Issue Detection and Initiation

• Identify triggers requiring root cause analysis such as audit findings, deviations, operational issues, or regulatory inquiries
• Ensure issues are documented and escalated appropriately for investigation

Root Cause Analysis

• Conduct structured root cause analysis using methodologies such as Fishbone diagrams and the Five Whys technique
• Analyze relevant data to identify primary and contributing factors responsible for operational or compliance issues

CAPA Planning and Development

• Develop corrective and preventive action plans with clear ownership, timelines, and verification metrics
• Ensure CAPA plans align with regulatory guidelines, internal procedures, and pharmacovigilance standards

Stakeholder Engagement

• Collaborate with cross-functional teams to gather insights and ensure complete root cause visibility
• Facilitate discussions with relevant departments to coordinate CAPA planning and monitoring

Client and Regulatory Interface

• Present root cause findings and CAPA proposals during client or regulatory review meetings
• Address feedback and ensure alignment with regulatory expectations

Implementation Tracking and Monitoring

• Oversee execution of CAPA activities and ensure completion within defined timelines
• Track milestones and escalate delays where necessary

Effectiveness Follow-up and CAPA Closure

• Conduct effectiveness checks to ensure corrective actions resolve the issue and prevent recurrence
• Prepare final CAPA documentation and obtain quality approvals for closure

Reporting and Continuous Improvement

• Generate CAPA dashboards, metrics, and trend reports to track open CAPAs and recurring issues
• Identify systemic gaps and recommend improvements to operational processes

Audit and Inspection Preparation

• Maintain inspection-ready CAPA documentation
• Support internal and external audits with required quality records

Required Qualifications

Educational Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, or related fields
• B.Pharm, B.Sc, M.Pharm, or M.Sc preferred

Experience and Skills

• 3 to 8 years of experience in pharmacovigilance quality systems, CAPA management, or regulatory compliance
• Experience supporting audits, inspections, and SOP documentation
• Strong analytical and root cause investigation skills
• Understanding of pharmacovigilance quality processes
• Excellent communication and stakeholder management abilities
• Ability to manage multiple quality activities and collaborate across teams

Technical Knowledge

• Understanding of pharmacovigilance quality systems and CAPA processes
• Familiarity with global regulatory guidelines including ICH Guidelines and Good Pharmacovigilance Practices

Salary Insights

Although the exact salary has not been disclosed, CAPA Manager roles in pharmacovigilance and regulatory operations typically offer competitive compensation depending on experience, expertise, and organizational policies.
Additional benefits may include professional development opportunities, exposure to global regulatory operations, and career growth within pharmacovigilance quality management.

Company Overview

Tata Consultancy Services is a leading global IT services, consulting, and business solutions organization. The company provides technology-driven services to organizations across industries including healthcare, pharmaceuticals, and life sciences.
Through its Business Process Services division, TCS supports global pharmaceutical companies with pharmacovigilance operations, regulatory compliance, clinical data management, and safety monitoring activities.
With a strong focus on innovation and regulatory excellence, the company helps life sciences organizations improve operational efficiency while maintaining high standards of compliance and patient safety.

FAQs

Who can apply for this role?
Candidates with Life Sciences or Pharmacy degrees such as B.Pharm, B.Sc, M.Pharm, or M.Sc and relevant experience in pharmacovigilance or CAPA management.

What experience is required for this position?
Applicants should have 3 to 8 years of experience in pharmacovigilance quality systems, CAPA processes, audits, or regulatory compliance activities.

What skills are important for a CAPA Manager?
Key skills include root cause analysis, CAPA planning, audit readiness, regulatory compliance knowledge, and stakeholder communication.

Does this role involve working with regulatory guidelines?
Yes. The role requires understanding and applying global pharmacovigilance regulations such as ICH guidelines and EU Good Pharmacovigilance Practices.

Application Tips

• Highlight experience in pharmacovigilance quality systems and CAPA management
• Mention involvement in audits, inspections, and SOP documentation
• Demonstrate expertise in root cause analysis tools such as Fishbone diagrams and Five Whys
• Include examples of successful CAPA implementation and compliance improvements
• Emphasize communication and collaboration with cross-functional teams